FDA holds off decision on psoriasis drug
New York - The Food and Drug Administration (FDA) has held off making a decision on the psoriasis drug ustekinumab (Johnson & Johnson), until they receive certain risk-mitigation information, but will not require new studies, Reuters reports.
New York
- The Food and Drug Administration (FDA) has held off making a decision on the psoriasis drug ustekinumab (Johnson & Johnson), until they receive certain risk-mitigation information, but will not require new studies, Reuters reports.
The FDA has issued a Complete Response letter for ustekinumab, which is sometimes issued when the agency needs more time to adequately review a drug, requesting additional information to ensure the drug’s benefits outweight the risks, according to a Johnson & Johnson press release.
The company says the letter also requests a medication guide and communication plan as part of the risk-mitigation information, which Johnson & Johnson says will be addressed next month, as the focus this month is on bringing the drug to market.
